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Prenatal therapy with pyrimethamine + sulfadiazine vs spiramycin to reduce placental transmission of toxoplasmosis : A multicenter, randomized trial

American Journal of Obstetrics and Gynecology Jun 09, 2018

Mandelbrot L, et al. - The efficacy and tolerance of pyrimethamine + sulfadiazine (PS) vs spiramycin (S) to reduce placental transmission were compared in this randomized, open-label trial. Researchers found that there was a trend towards lower transmission with PS, yet it didn't reach statistical significance, possibly for lack of statistical power because enrollment was discontinued. In the PS group, there were also no fetal cerebral toxoplasmosis lesions.

Methods
  • Researchers performed a randomized, open-label trial in 36 French centers, in order to compare pyrimethamine (50 mg QD) + sulfadiazine (1g TID) with folinic acid vs spiramycin (1g TID) following toxoplasmosis seroconversion.

Results
  • From 11/2010 to 01/2014, one hundred forty-three women were randomized.
  • An amniocentesis was later performed in one hundred thirty-one cases, with a positive T. Gondii PCR in 7/67 (10.4%) in the PS group vs 13/64 (20.3%) in the S group.
  • It was observed in the findings that cerebral ultrasound anomalies appeared in 0/73 fetuses in the PS group, vs 6/70 in the S group (p=0.01).
  • It was noted that two of these pregnancies were terminated.
  • Findings revealed that transmission rates, excluding 18 children with undefined status, were 12/65 in the PS group (18.5%), vs 18/60 in the S group (30%, p=0.147), equivalent to an Odds ratio = 0.53 (95% CI 0.23-1.22) and which after adjustment tended to be stronger (p=0.03 for interaction) when treatment began within 3 weeks of seroconversion (95% CI 0.00-1.63).
  • Data reported that both with PS two women had severe rashes.
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